UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003122 |
|---|---|
| Receipt number | R000003391 |
| Scientific Title | Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer |
| Date of disclosure of the study information | 2010/02/03 |
| Last modified on | 2014/02/01 14:19:31 |
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Basic information
Public title
Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Acronym
Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Scientific Title
Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Scientific Title:Acronym
Multi-center Study of Detection of Synchronous and Metachronous Contralateral Breast Cancer with Magnetic Resonance Imaging in Patients with Unilateral Breast Cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the clinical usefulness of breast MRI for detection of contralateral breast cancer in the patient with breast cancer
Basic objectives2
Others
Basic objectives -Others
We examined the significance of performing breast contrast-enhanced MR imaging, in addition to palpation and mammography, in screening for contralateral breast cancer in patients with unilateral breast cancer or a history of unilateral breast cancer. The sensitivity, specificity, and positive and negative predictive values for detection of contralateral breast cancer with contrast-enhanced MR imaging were determined in cases diagnosed as free from abnormal findings using palpation and mammography. These results were used to examine the significance of performing additional contrast-enhanced MR imaging. We also performed a questionnaire-based investigation of background factors including eating habits, fitness habits, smoking, favorite foods and beverages, family history, history of hormonal therapy, and academic background to examine possible risk factors for development of bilateral breast cancer, based on our data for the occurrence of synchronous and metachronous breast cancer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity, positive and negative predictive value of breast MRI to detect the contralateral breast cancer
Key secondary outcomes
Safety of breast MRI, identification of lifestle risk factors about contralateral breast cancer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI evaluation of bilateral breast
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
histologically proven invasive breast cancer
ipsilateral breast cancer
no evidence of metastasis
Key exclusion criteria
bilateral breast cancer
Has a contraindication to undergoing breast MRI
Patient is pregnant
Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama university hospital
Division name
Breast and endocrine surgery
Zip code
Address
2-5-1 Shikata-cho, Kita ward, Okayama city
TEL
086-235-7265
ntaira@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama university hospital
Division name
Breast and endocrine surgery
Zip code
Address
2-5-1 Shikata-cho, Kita ward, Okayama city
TEL
086-235-7265
Homepage URL
ntaira@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Cancer Control from Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases
Kawasaki medical school hospital
Saitama medical center
Kitasato university
Niigata cancer center hospital
Rinku general medical center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003391
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
